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Immunoassay for the qualitative detection of methamphetamine, opiates, cocaine metabolites, THC metabolites, phencyclidine, benzodiazepines, barbiturates, tricyclic antidepressants, methadone, and amphetamine in human urine to assist in the screening of druse samples. The detection cut-off concentrations are as follows:

MET d-Methamphetamine 1000 ng/mL
OPI Morphine 2000 ng/mL
COC Benzoylecgonine 300 ng/mL
THC 11-nor-Δ9-9-carboxylic acid 50 ng/mL
PCP Phencyclidine 25 ng/mL
Benzodiazepine Oxazepam 300 ng/mL
Barbiturate Secobarbital 300 ng/mL
Methadone Methadone 300 ng/mL
TCA Nortriptyline 1000 ng/mL
Amphetamine d-Amphetamine 1000 ng/mL

Immunoassay for the qualitative detection of THC, opiates, cocaine, amphetamine, benzodiazepines barbiturates, tricyclic antidepressants, and phencyclidine in human urine to assist in screening of drug of abuse samples.

Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), phencyclidine and/or their metabolites in human urine to assist in screening of drug of abuse samples.

Immunoassay for the qualitative detection of THC, opiates, cocaine, methamphetamine (or amphetamine), and/or their metabolites in human urine to assist in screening of drug of abuse samples.

Immunoassay for the qualitative detection of THC, opiates, cocaine, and/or their metabolites in human urine to assist in screening of drug of abuse samples.

Immunoassay for the qualitative detection of amphetamine or methamphetamine, opiates, of abuse Immunoassay for the qualitative detection of anyman urine to assist in screening of drugs of abuse metabolites, THC metabolites, and phencyclidine in human urine to assist in niciabonici), 1999-19-19 samples. The detecting cut-off concentrations are as follows:

THC 11-nor-Δ9-9-carboxylic acid 50 ng/mL
OPI Morphine 2000 ng/mL
COC Benzoylecgonine 300 ng/mL
AMP Amphetamine 1000 ng/mL
MET D-Methamphetamine 1000 ng/mL
PCP Phencyclidine 25 ng/mL

Not Found

The provided text describes the regulatory clearance for the AccuSign® DOA drug screening devices but does not contain information about acceptance criteria or a detailed study proving the device meets those criteria. The document focuses on the FDA's substantial equivalence determination for marketing the device.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size and data provenance for a test set.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study results.
• Standalone performance details.
• Type of ground truth used.
• Training set sample size.
• How ground truth for the training set was established.

The text does provide information on the Indications for Use and detection cut-off concentrations for various drugs, which are essential specifications of the device.

However, since the core request is to describe the acceptance criteria and the study that proves the device meets them, and this information is explicitly not present in the provided text, I must state that the document does not contain the requested details.

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